BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 6673092 · Received June 28, 2017

    Report

    Report Number
    1000113657-2017-01106
    Event Type
    Malfunction
    Date Received
    June 28, 2017
    Date of Event
    June 6, 2017
    Report Date
    June 28, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT # (B)(4). RETURNED METER EVALUATED WITH NO DEFECT FOUND. TEST STRIP VIAL RETURNED WITH ONE STRIP ONLY - UNABLE TO TEST. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-58 USER HAD AN INACCURATE REFERENCE: SELF: THE PERSON IS USING THEMSELVES AS THE REFERENCE OR HOW THEY FEEL AT THE TIME THEY RUN THE BLOOD TEST. NOTE: MANUFACTURER CONTACTED CUSTOMER ON 6/12/2017 IN A FOLLOW-UP CALL IN ORDER TO ENSURE THE CUSTOMER'S CONDITION SINCE THE INITIAL CALL; CUSTOMER CONDITION IMPROVED. NO SYMPTOMS OR MEDICAL ATTENTION REPORTED SINCE THE ORIGINAL CALL. CUSTOMER SATISFIED WITH THE REPLACEMENT PRODUCT.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 54 AND 93 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT IS 110 MG/DL. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT WHEN HE OBTAINED THE RESULT OF 54 MG/DL HE WAS SWEATY, DIZZY AND SHAKING A BIT; CUSTOMER STATED HE ATE ONE FIG NEWTON, SIX PEANUT BUTTER COOKIES AND ONE PIECE OF CORNBREAD TO TRY AND BRING HIS SUGAR UP. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 106 MG/DL USING TRUEMETRIX METER AND 137 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/31/2018 AND OPEN VIAL DATE AT TIME OF CALL WAS A FEW DAYS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (CUSTOMER IS CONCERNED WITH THE RESULTS OF 54, 143, 184, 93 AND 222 MG/DL IN THE METERS MEMORY): THE 54MG/DL (B)(6) 2017 02:45 PM FASTING:YES, THE 143MG/DL (B)(6) 2017 12:45 PM FASTING:YES, THE 184MG/DL (B)(6) 2017 07:53 AM FASTING:YES, THE 93MG/DL (B)(6) 2017 06:32 AM FASTING:YES, THE 222MG/DL (B)(6) 2017 03:27 AM FASTING:YES. MEMORY CONCERNS:CUSTOMER IS CONCERNED WITH THE RESULTS OF 54, 143, 184, 93 AND 222 MG/DL IN THE METERS MEMORY. CUSTOMER STATES THAT THE RESULTS THAT HE IS GETTING FROM HIS METER IS LOWER THAN HIS NORMAL RANGE OF <110MG/DL. CUSTOMER DID NOT PROVIDE CCR WITH A LOWER RANGE NUMBER FOR THE EXPECTED RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455001 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MU2379 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY